A Pill to Prevent Heart Disease?

A few years ago there was a lot of publicity about a drug that would combine cholesterol-lowering action and treatment of high blood pressure in a single pill. What became of this concept?

– September 14, 2012

You’re referring to the "polypill," an idea proposed by British researchers in an article published in the June 28, 2003, issue of the British Medical Journal. They envisioned a pill combining drugs to lower cholesterol and blood pressure, plus aspirin and folic acid. The researchers claimed that if everyone over the age of 55 took such a pill daily, heart disease incidence would drop by more than 80 percent.

In theory, the polypill strategy would reduce the major cardiovascular risk factors: high cholesterol, high blood pressure and high homocysteine levels; the aspirin would reduce inflammation as well as the clotting tendency of blood.

In 2009, a 12-week polypill trial involving 2,053 people, all with only a single risk factor for heart disease (such as high blood pressure or high cholesterol) was completed at 50 medical centers in India. Only 412 of the participants received the actual polypill; the rest were given individual drugs or a combination of drugs for high blood pressure, high cholesterol. Results showed that the polypill reduced systolic blood pressure (the top number) by 7.4 points and diastolic blood pressure (the bottom number) by 5.6 points, better than reductions typically seen with individual blood pressure drugs. The statin in the polypill reduced LDL ("bad") cholesterol almost as much as the same statin given alone. Researchers said that the drop in blood pressure would lower the risk of heart disease by 24 percent and the risk of stroke by 33 percent and that the cholesterol reduction would lower heart disease risk by 27 percent and stroke risk by 8 percent.

Another, smaller study in Britain, published on July 18, 2012 in the journal PLoS ONE, found that the polypill reduced blood pressure by 12 percent and lowered LDL ("bad") cholesterol by 39 percent. Based on these findings, one of the researchers told a British newspaper that if everyone started taking the drug combo at age 50, an estimated 28 percent would avoid or delay a heart attack or stroke during their lifetime, and that if only half of people 50 and older took it daily, about 94,000 fatal and non-fatal heart attacks and strokes could be prevented each year in the U.K.

A total of 84 men and women over age 50 participated in the study. Half the group took the polypill for three months, while the other half took a placebo. At the three-month mark, the participants were switched to the opposite pill.

The researchers reported that of their 84 participants, 24 complained of side effects, mainly muscle aches, while on either the polypill or the placebo, but none felt that the aches were so bad that they would stop taking the pill. However, such a small, short study doesn’t reveal what long-term side effects might arise from this combination of drugs.

I can see the appeal of the polypill, but I worry that it fosters the notion that everything is treatable by drugs rather than by improving lifestyle, an objection that surfaced in Britain when the new study was published.

The polypill is still being studied and won’t be available to patients anytime soon. Stay tuned for future developments.

Andrew Weil, M.D.

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